Cognitive Behavioural Group Therapy for Perinatal Anxiety

NCT02850523 | Completed

• 1 other identifier: TCRA-SG2
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the effectiveness of a 6-week, group-based, cognitive behavioural therapy (CGBT) program for women with anxiety disorders (with or without comorbid depressive symptoms) during pregnancy or early postpartum. The CBGT program was evaluated compared to a 6-week waitlist condition.

Conditions

Perinatal Anxiety

Keywords

Cognitive-behavioural therapy (CBT)

Outcome Measures

Primary Outcomes (1)

• State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)

  Changes in anxiety symptoms will be assessed through the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA; Gros et al.,2007) to examine whether CBT for perinatal anxiety is effective in reducing anxiety symptoms. Items on the STICSA are rated on a 4-point likert scale ranging from 1 (not at all) to 4 (very much so), with higher scores indicating worse anxiety symptoms. The STICSA has two subscales (i.e., cognitive subscale and somatic subscale) and a total score that will be used in analysis. Ten items comprise the cognitive subscale, meaning scores can range from 10-40. Eleven items comprise the somatic subscale, meaning scores can range from 11 -44. The total score is a sum of both subscales with possible total scores in the range of 21-84.

  6 weeks

Secondary Outcomes (19)

• Edinburgh Postnatal Depression Scale (EPDS)

  6 weeks

• Penn State Worry Questionnaire (PSWQ)

  6 weeks

• Intolerance of Uncertainty Scale (IUS-12)

  6 weeks

• Multidimensional Perfectionism Scale (MPS)

  6 weeks

• Multidimensional Parenting Perfectionism Scale (MPPQ)

  6 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

After an initial assessment, the experimental group will receive 6 weekly sessions (2 hours long) of group Cognitive Behavioural Therapy for Perinatal Anxiety (n=6 per group) for perinatal anxiety. They will then be re-assessed at post-treatment and 3 months post-treatment to determine the effectiveness of the treatment and whether these effects are maintained 3 months after treatment.

Other: Cognitive Behavioural Therapy for Perinatal Anxiety

Waitlist Control

NO INTERVENTION

After an initial assessment, the wait-list control group will not receive any treatment for 6 weeks. They will then be re-assessed after 6 weeks and this data will be used to compare this group to the experimental group to determine the effectiveness of the treatment. After this re-assessment they will be offered the same treatment as the experimental group: 6 weekly sessions (2 hours long) of group Cognitive Behavioural Therapy for Perinatal Anxiety

Interventions

Cognitive Behavioural Therapy for Perinatal Anxiety OTHER

The treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population.

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• severe depression or active suicidal ideation
• current psychosis or substance use disorder

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

Women's Health Concerns, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Location

Related Publications (2)

• Green SM, Haber E, Frey BN, McCabe RE. Cognitive-behavioral group treatment for perinatal anxiety: a pilot study. Arch Womens Ment Health. 2015 Aug;18(4):631-8. doi: 10.1007/s00737-015-0498-z. Epub 2015 Feb 5.

  PMID: 25652951 BACKGROUND

• Green SM, Donegan E, McCabe RE, Streiner DL, Furtado M, Noble L, Agako A, Frey BN. Cognitive Behavior Therapy for Women With Generalized Anxiety Disorder in the Perinatal Period: Impact on Problematic Behaviors. Behav Ther. 2021 Jul;52(4):907-916. doi: 10.1016/j.beth.2020.11.004. Epub 2020 Nov 20.

  PMID: 34134830 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sheryl Green, PhD, C.Psych

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors conducted assessments of symptoms and overall functioning at baseline, 6-weeks post-baseline, and (for participants assigned to CBGT) at 3-months post-treatment. Assessors were unaware of participants' assigned condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cinical Health Psychologist

Model Details: A single-blind, randomized controlled trial was conducted to evaluate the effectiveness of a new group-based cognitive-behavioural therapy (CBGT) for women with anxiety during pregnancy or in the early postpartum.

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 1, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)